Compliance-assisting module for an inhaler

ABSTRACT

An inhaler includes a mouthpiece cover, a pressure sensor, a first indicator and a second indicator. The first indicator may be configured to indicate based on a state of the cover, and the second indicator may be configured to indicate based on an output of the pressure sensor. For example, when the mouthpiece cover opens, the first indicator may illuminate and a dose of medication may be transferred from a reservoir to a dosing cup. The second indicator may illuminate if an amount of inhaled medication reaches a predetermined threshold for successful inhalation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the National Stage Entry under 35 U.S.C. § 371Patent Cooperation Treaty Application No. PCT/EP2015/069781, filed Aug.28, 2015, which claims the benefit of U.S. Provisional Application No.62/043,120, filed Aug. 28, 2014, the contents of which are incorporatedby reference herein.

BACKGROUND

Inhalers or puffers may be used for delivering medication into the bodyvia the lungs. They can be used, for example, in the treatment of asthmaand chronic obstructive pulmonary disease (COPD). Types of inhalers mayinclude metered dose inhalers (MDIs), dry powder inhalers (DPIs) andnebulizers.

A common problem faced in respiratory drug delivery is how to monitorpatient adherence and compliance. Adherence deals with the patientfollowing the prescription label, for example taking the prescribednumber of doses per day. For example, if the prescription calls for twodoses each day, and the patient is taking two doses a day, they areconsidered 100% adherent. If the patient is only taking one dose a day,they are only 50% adherent. In the latter case, the patient is notgetting the treatment prescribed by their doctor.

Compliance, on the other hand, relates to how the patient uses theirdrug delivery device. If used in the manner recommended for effectivetreatment, they are 100% compliant. If not used properly however, theyare less than 100% compliant. Use of a breath-actuated inhaler (e.g., adry powder inhaler (DPI)) involves inhaling in a particular way; forexample the inhalation may need to be long enough and hard enough toentrain a full dose of medicament. For some patients, for examplechildren and the elderly, meeting the requirements for full compliancemay be difficult. Failing to achieve 100% compliance can reduce theeffectiveness of the prescribed medicament.

It is difficult for a patient to determine whether he or she inhaled theprescribed dose of medication and thus to verify compliance with theprescription. Especially for DPIs, a patient may not immediately noticethat medication is being inhaled (e.g., because the particles are sosmall they may not be felt or tasted). A patient may learn of inhalationafter seeing the medical effects and still may not know whether theamount of inhaled medication complies with the prescription.

SUMMARY OF THE INVENTION

The present disclosure generally relates to assisting patient compliancewith medicament administration via an inhaler. For example, thedisclosure may relate to the use of indicators to indicate when theinhaler is ready for releasing a dose and when the patient has inhaledsufficient to receive the recommended dose.

An inhaler may include a mouthpiece cover, a pressure sensor, a firstindicator, and a second indicator. The first indicator may be a firstlight and the second indicator may be a second light. The firstindicator may be a first state of a light and the second indicator maybe a second state of the light. The first indicator may be configured toindicate based on a state of the mouthpiece cover. For example, thefirst indicator may be configured to illuminate based on an open stateof the mouthpiece cover, where for example, medication may be ready forinhalation based on the open state of the mouthpiece cover. For example,medication may be transferred from a reservoir to a dosing cup based onthe open state of the mouthpiece cover. The second indicator may beconfigured to indicate based on an output of the pressure sensor. Forexample, the second indicator may be configured to illuminate based on apressure measurement in the mouthpiece or elsewhere in the inhalerexceeding a predetermined threshold. The predetermined threshold may beassociated with administration of medication.

An inhaler may include a mouthpiece cover, a pressure sensor, and/or alight. The light may be configured to provide a first indication basedon a state of the mouthpiece cover and a second indication based on anoutput of the pressure sensor. The first indication and the secondindication may be different colors of the light. At least one of thefirst indication and the second indication may be a provided by flashingthe light. The inhaler may include a dosing cup. A dose of medicationmay be released to the dosing cup based on a movement of the mouthpiececover.

An inhaler may include a mouthpiece cover, a first light, and a secondlight. The first and second lights may be configured to indicate thatthe inhaler is ready for inhalation based on a state of the mouthpiececover and to indicate inhalation. The first light may be configured toindicate that the inhaler is ready for inhalation based on themouthpiece cover reaching an open state. The inhaler may include adosing cup. A dose of medication may be released to the dosing cup basedon a movement of the mouthpiece cover. The first light may indicate thatthe inhaler is ready for inhalation based on the inhaler being in anupright orientation.

The inhaler may include a sensor configured to provide an output basedon air flow through a mouthpiece of the inhaler, which for example maybe indicative of user inhalation. For example, the second light may beconfigured to indicate inhalation based on the sensor output. The secondlight may be configured to indicate inhalation based on a determinationthat an amount of inhaled medication has (e.g., and/or has not) reacheda predetermined threshold (e.g., using the sensor). For example, thesecond light may be configured to flash to indicate that a sensormeasurement has reached a first threshold (e.g., indicative of userinhalation) and to turn on based on a determination that a sensormeasurement has reached a second predetermined threshold (e.g.,indicative that an amount of inhaled medication has be delivered to theuser).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an example of an inhaler with an indicator.

FIG. 1B illustrates an example of a partially-exploded view of aninhaler.

FIGS. 2A-C illustrate the top portion of the internal structure of anexample inhaler.

FIG. 3 illustrates an example internal structure of the inhaler.

FIG. 4 is a schematic diagram of example electronics in an inhaler.

FIGS. 5A-C illustrate an example electronics module in an inhaler.

FIG. 6 shows a cross-section view of an inhaler mouthpiece with a sensorin an example configuration.

FIGS. 7A-F illustrate examples of an inhaler providing indications.

FIG. 8 is a flowchart illustrating an example compliance assistingmethods with at least two indicators (e.g., two lights).

FIG. 9 is a flowchart illustrating an example compliance assistingmethod with a single indicator (e.g., a single light).

DETAILED DESCRIPTION

FIG. 1A illustrates an example inhaler 100 with an indicator. Theinhaler 100 may have a mouthpiece 170. The inhaler 100 may have a cover180 for the mouthpiece 170. The inhaler 100 may have indicators 152(e.g., visual and/or audible indicators) to provide indication to auser. The indicators 152 may comprise two or more lights, for example,two lights as shown in FIG. 1A. The indicators 152 may be, for example,a single light. For example, the single light may provide multipleindications (e.g., a first color for a first indication, a second colorfor a second indication). The indicators 152 may comprise an audibleindicator, such as a buzzer or speaker, for example. The indicators 152may comprise one or more devices that provide haptic feedback. Theindicators 152 may indicate the state of the inhaler 100 or the state ofinhalation by a user. The indication may provide an instruction to itsuser, for example, such that the user knows when to start inhaling,continue inhaling, stop inhaling medication, a dose reminder, and/or thelike. The indication may be performed by turning on one or more lights,turning off one or more lights, and/or flashing one or more lights. Theindication may be performed through multiple colors or different typesof flashing. For visual indicators, the indicators 152 may be locatednear the top of the inhaler 100 (for example, as shown in FIG. 1A). Forexample, the indicator 152 may be located near the top of the inhaler100 such that a user can see the indicator easily while using theinhaler 100. The indicator 152 may include a screen that displaysmessages, pictographs, and/or colors for indication. The indicator 152may indicate using sound or vibration. The indicator 152 may be capableof providing one or a mix of visual, audial, haptic indication.

FIG. 1B shows a partially exploded view of the example inhaler 100. Amouthpiece 170 may be exposed by removing (e.g., swinging down) a cover180. The downward motion of the mouthpiece 170 may push up a yoke 190.The yoke 190 may be a vertical bar that may reach an electronics module,or a PCB 150.

The PCB 150, which may carry a processor and transmitter, may beincorporated into the top of the inhaler 100 body. A collar 197 aroundthe PCB 150 may be clipped onto the top of the yoke (not shown) towardsthe end of manufacture of the inhaler 100. This may be done followingsterilization of parts of the inhaler body. This may be advantageoussince the sterilization process may damage the sensitive electronics onthe PCB 150.

The yoke 190 may be configured to rise when the mouthpiece cover 180 isopened. This may push the horizontal top part of the yoke 190 up toclose the tactile switch 195. When the switch 195 is closed, anelectrical connection may be formed between the PCB 150 and a battery155, such as a coin cell, so that the PCB 150 may be powered up when themouthpiece cover 180 is open. In an example, the PCB 150 may always beconnected to the battery 155, but closing of the switch 195 (e.g., oractivation of some other switching means, e.g. an optical sensor, anaccelerometer or a Hall effect sensor) may wake the PCB 150 from apower-conserving sleep mode. For example, the PCB 150 may always bepowered on and the circuit of the electronics module may be in standby,and opening of the mouthpiece cover 180 may wake up the circuitry of theelectronics module (e.g., bring the electronics module out of sleep modeand into a full powered on state). Indicator light emitting diodes(LEDs) visible through (e.g., optionally colored) windows or light pipesshown on the exterior of the inhaler 100, for example, in a positionvisible to a user during dosing, may also be powered by battery 155 andmay be controlled by a processor on the PCB. The indicator 152 may beused to provide information to a user and/or caregiver by indicating,for example with different color and flash combinations, that e.g. themouthpiece cover is open (e.g., and therefore the inhaler is primed fordosing) and/or it is time to refill a prescription and/or that (e.g.,according to processing of the pressure sensor readings) dosing iscomplete/has not been fully completed.

FIGS. 2A-C show an example arrangement of the top portion of theinternal structure of an example inhaler (for example, the inhaler 100).A yoke 290, linked to a hinged mouthpiece cover (not shown) carries abellows 291, made of, for example, a partially compliant material. FIG.2A shows a bellows position when the cover is closed. A foot of a springarm 292 may be received in a recess 293 in the upper wall of thebellows. The bottom of the recess 293 therefore may push on the lowersurface of the foot such the spring arm is biased upwards. This maycause a head of the spring arm 292 to close a switch 295 which keeps aPCB 250 in sleep mode.

FIG. 2B shows the arrangement as opening of the cover is begun, when theyoke 290 and therefore the bellows 291 move slightly upwards. The springarm 292 may remain contacting the switch 295 and the compliance of thebellows material may relieve any additional strain which would otherwisebe put on the switch since the bottom of the recess 293 may bend to takethe strain.

FIG. 2C shows the arrangement when the cover is fully open. The yoke 290and bellows 291 may have moved down clear of the spring arm 292, whichrelaxes down away from switch 295. Switch 295 may therefore be opened,waking the PCB 250.

FIG. 3 shows is an example diagram of an internal structure of aninhaler (e.g., the inhaler 100). For example, opening the mouthpiececover may cause a transfer of medication from a reservoir to a dosingcup. The inhaler 300 may have a spring 392 and a bellows 391. Theopening of the cover 380 may cause the compression or decompression ofthe spring 392. The spring 392 may compress the bellows 391 when thecover 380 opens from the mouthpiece 370. The compressed bellows 391 mayprovide pressure such that medication in a reservoir 378 flows to adosing cup 375. Between the reservoir 378 and the dosing cup 375, theremay be a hopper allowing the flow of medication. The hopper may slide toa position allowing the transfer of medication from the reservoir 378into the dosing cup 375, for example, only when the cover 380 is open.The medication from the dosing cup may flow through a flow channel 320when a user inhales using the mouthpiece 370.

FIG. 4 is a schematic diagram of example electronics in an inhaler(e.g., the inhaler 100). The inhaler may comprise an electronics module400. The electronics module 400 may have a processor 457, and a powersource 455, a memory 445, indicator(s) 452, a switch 495, a sensor 410,and/or a transceiver 460. The processor 457 may be connected to each ofthe components. The switch 495 may be connected to a mouthpiece througha yoke, for example, as described in connection with FIG. 1B. The switch495 is not limited to a mechanical switch, and it may, for example, bean electrical switch. The sensor 410 may provide information to theprocessor 457 about a pressure change (e.g., pressure difference) in themouthpiece of the inhaler (e.g., or other part of the inhaler). Forexample, the sensor 410 may provide an instantaneous pressure reading tothe processor or aggregated pressure reading over time. For example, thepressure reading may be in terms of Peak Inspiratory Flow, acceleration,total volume, total time, and/or the like. The pressure reading may bein terms of one or a combination of amplitude, acceleration, volume,and/or the like. The pressure reading (e.g., a pressure drop) may bemeasured elsewhere in the inhaler 700, and the inhaler 700 may calculatethe flow in the mouthpiece accordingly. The pressure reading may beindicative of an amount of airflow through the mouthpiece of theinhaler, which for example, may be indicative of medication beinginhaled by a user. As such, the sensor 410 may provide information tothe processor 457 relating to the pressure reading, the amount ofairflow through the mouthpiece (e.g., and/or other part of the inhaler),and/or medication being inhaled by a user. The processor 457 may make adetermination (e.g., regarding one or more indicators) based on thepressure reading of the sensor 410. For example, the processor 457 maycalculate the amount of air or medication inhaled based on the pressurereading provided by the sensor 410. The sensor 410 may have a separateprocessor to calculate the level of air or medication inhaled andprovide it to the processor 457.

Based on the information received from the switch 495 and/or the sensor410, the processor 457 may determine that the pressure reading (e.g.,which may be indicative of medication inhaled by a user) reached apredetermined level. There may be a lookup table for the predeterminedlevel with which the processor compares the pressure reading. When thepredetermined level is reached, the processor 457 may send a signal toone or more indicator(s) 452 to indicate the state of the inhaler. Theprocessor 457 may store in memory the pressure reading, a time stamp forthe pressure reading, and/or information derived based on the pressurereading (e.g., medication dosed, medication administered to the user,medication administered in full to the user, air flow through themouthpiece, etc.). For example, the processor 457 may access information(e.g., a lookup table for the predetermined level of medication) from,and store data in, any type of suitable memory, such as non-removablememory and/or removable memory. The non-removable memory may includerandom-access memory (RAM), read-only memory (ROM), a hard disk, or anyother type of memory storage device. The removable memory may include asubscriber identity module (SIM) card, a memory stick, a secure digital(SD) memory card, and the like. The processor may access informationfrom, and store data in, memory that is not physically located withinthe inhaler, such as on a server.

The processor 457 may comprise a microcontroller, a programmable logicdevice (PLD), a microprocessor, an application specific integratedcircuit (ASIC), a field-programmable gate array (FPGA), or any suitableprocessing device, controller, or control circuit. The processor 457 maycomprise an internal memory. The processor 457 may receive power fromthe power source 455, and may be configured to distribute and/or controlthe power to the other components in the inhaler 400. The power supplymay be any suitable device for powering the inhaler. The switch 495 maynot be connected to the processor 457, but the power source 455. Thepower source may be directly connected to one or more of the sensor 410,memory 445, the indicator(s) 452, and transceiver 460.

Indicators and an electronics module may be permanently attached to aninhaler. As shown in FIG. 1B, the indicators and the electronics modulemay be located at the top of the inhaler. In some embodiments, theelectronics module may be located in a different location. For example,an inhaler may have a mountable cap to mount it on top of an inhaler.The cap may contain indicators and an electronics module to control theindicators. Indicators may be added to or removed from an existinginhaler without affecting its operation, for example, by using amountable cap.

FIG. 5 illustrates how an electronics module 550 (e.g., compliancemodule) may be incorporated into the top of an inhaler (e.g., theinhaler 100) whether the indicators and electronics module are permanentor removable. The electronics module 550 may be an example of theelectronics module 400 of FIG. 4. FIG. 5A shows an example defaultposition of a yoke (e.g., retainer ring) 590, pushing up a tactileswitch 595 to open it. With the switch 595 open, there may be noelectrical connection between the compliance module 550 and a battery555 such as a coin cell. FIG. 5B shows an example position of retainerring 590 when the inhaler is primed for use, lowered with respect to theswitch 595 to close it so that compliance module 550 is powered.

FIG. 5C illustrates the final stages of manufacture of the inhaler shownin FIGS. 5A and B. The compliance module 550 may be lowered onto theinhaler body then a cap 598 may be clipped in place. Like the previousexamples, LED indicators 552 may be provided.

Example methods of using a sensor to detect inhalation are providedbelow. Although the examples below use a pressure sensor, specifically abarometric pressure sensor, an inhaler (e.g., the inhaler 100) may useother types of sensors to measure the inhalation.

A spirometer is an apparatus for measuring the volume of air inspiredand expired by a patient's lungs. Spirometers measure ventilation, themovement of air into and out of the lungs. From the traces, known asspirograms, output by spirometers, it is possible to identify abnormal(e.g., obstructive or restrictive) ventilation patterns. Spirometers mayuse a variety of different measurement methods including pressuretransducers, ultrasonic and water gauge.

In order to monitor the flows associated with breathing, a pressuresensor may be convenient because pressure information can be used todetermine flow, which can then be used to determine volume.

Pressure sensors used for breath detection may measure the pressuredifference across a section of the patient airway. This may be doneusing two connections, by tubing or other suitable conduit, to connectthe sensor to the airway. It may also be possible to use a singleconnection to the airway, with the other port open to the atmosphere. Asingle port gauge type sensor can also be used if the pressure withinthe airway is measured both before and after flow is applied, thedifference in readings representing the desired pressure drops acrossthe air path resistance.

In addition to the differential (two port) type pressure sensors and thesingle port-gauge type sensors, with separate measurements made beforeand after use, absolute or barometric pressure sensors may be available.Barometric pressure sensors are referenced to vacuum. They are sometimesreferred to as altimeters since altitude can be deduced from barometricpressure readings.

However, with miniaturization, including the introduction of MEMS andNEMS technologies, much improved sensors are now available. A MEMSbarometric sensor may be capable of operation from 20 kPa to 110 kPa andcan detect flow rates of less than 30 μm (liters per minute) whenpneumatically coupled to a flow path having a known flow resistance.

Using a barometric sensor may enable use of the barometric pressure as abaseline throughout the measurement cycle, and thus it may address theuncertainty of other single port approaches.

Also, having knowledge of the local barometric pressure may provide someinsight into patient lung function. It is suspected that changes inatmospheric pressure, such as those associated with approaching stormfronts, may have an effect on patient breathing, possibly even relatedto asthma and COPD events.

Barometric pressure sensors may already be in stressed condition, havingan integral reference port sealed within the device under vacuum. Thismeans that they have low hysteresis in the region of interest.

Due to the extremely small size and mass of their sensing elements, MEMSsensors may be capable of reacting to extremely small pressure changes.Some are capable of resolving pressure changes as low as 1 Pa.

For example, the Freescale MPL3115A2 MEMS barometer/altimeter chip(pressure 20 sensor) is digital, using an I²C interface to communicatepressure information to a host micro-computer.

MEMS pressure sensors can be packaged in metal. This may provide RFshielding and good thermal conductivity for temperature compensation.

MEMS pressure sensors are also low cost, exhibit low power consumptionand are very small. This makes them especially suitable for use inportable and/or disposable devices which may, for example, be powered bybatteries such as coin cells.

The small size of MEMS pressure sensors may make it easy to incorporatethem into existing designs of inhalers. It may be easier to incorporatethem in or close to a mouthpiece to more accurately measure the pressurechange caused by a patient's inhalation or exhalation.

A miniature barometric pressure sensor can be connected directly to thepatient airway using only a small hole to the air path which does notrequire tubing of any kind. This may reduce the possibility of moisturecondensation and potential bacterial growth associated with elastomerictubing. An internal seal, for example a gel seal, can be included toprotect the sensor element from contamination.

FIG. 6 shows a cross-section view of an inhaler mouthpiece with a sensorin an example configuration. A miniature barometric pressure sensor 610may be placed against the flow channel 620 through which a patientbreathes. Airflow may be substantially axial as indicated by arrow 630.The sensor port 611 may be sealed in line with an opening 621 in flowchannel wall 622 by a pneumatic (e.g., airtight) seal 640. (Note that,so long as there is a pneumatic connection between the sensor port andthe flow channel, the seal need not be completely airtight.) Sensor port611 may comprise a filter, for example an air-permeable,water-impermeable filter. The flow channel and the seal may be formed bya two-shot molding process. The pressure sensor 610 may be mounted on aprinted circuit board (PCB) 650 to provide connection to power sourcesand other electronics.

The miniature pressure sensor (e.g., the entire miniature pressuresensor) may be encapsulated within a chamber adjacent to the flowchannel, for example, instead of positioning the seal 640 around thechannel between opening 621 and sensor port 611. Pneumatic seal may belocated outside of the sensor footprint and may extend all the way fromthe exterior of flow channel wall to the surface on which the sensor maybe mounted (for example the component surface of a PCB).

MEMS sensors may be available with built-in temperature compensation. Inan example, external thermal sensors may be used. In an example,external thermal sensors may not be used. Compensation may be providedright at the measurement site, increasing the accuracy of thecompensation. A MEMS sensor with built-in temperature compensation mayalso act as a compact breath thermometer, providing further informationto the patient and/or their caregiver. If the housing of the sensor ismetal, then not only may the sensitive internal circuitry be isolatedfrom RF fields, such as those associated with mobile phones or nearbydisturbances, but the sensor may also rapidly equilibrate to the localtemperature in order to provide optimum temperature compensation.

The addition of a miniature barometric pressure sensor anywhere in theairflow path through the inhaler or anywhere in fluid communication withthe airflow path may enable compliance monitoring since such a miniaturesensor may collect sufficient data to indicate whether or not thepatient inhaled in an appropriate manner (e.g. hard enough and for longenough) to entrain a full dose of medicament. This information, combinedwith a signal originating from the dose metering system indicating thata bolus of medicament was made available to the flow channel throughwhich the patient inhales prior to the inhalation, may be sufficient toconfirm that a dose has been successfully administered.

It should be noted that due to their small size, MEMS pressure sensorscan be used to monitor patient flow through, for example, nebulisers,DPIs or pMDIs, thus facilitating low cost compliance monitoring, inaddition to/in place of adherence monitoring, which confirms deviceactuation. Said compliance monitoring could be implemented using anaccessory device that couples to the dosing device through a small holeto the airway to be monitored, or in the dosing device itself. The smallsize, high performance and low cost of MEMS sensors may make themideally suited to such applications where size and weight are majorconsiderations for users who may have to carry their inhaler with themat all times.

If output from the miniature pressure sensor is digital, all low levelsignal processing can be done within the sensor, shielding it fromoutside interference. This makes it possible to work with signals of theorder of tens of Pascals without much difficulty, something thattraditional sensors with external circuitry would be challenged to do.

The sensor may, for example, be used in a breath actuated dry powderinhaler. These inhalers may be configured such that inhalation by theuser through the mouthpiece results in an airflow through the deviceentraining dry powder medicament. The inhalation also may result inanother airflow entering the inhaler from outside. The inhaler maycomprise a swirl chamber in which the two airflows collide with oneanother and the chamber walls to break down aggregates of the dry powdermedicament for more effective delivery.

For example, the sensor may be used in a breath actuated pressurizedaerosol inhalers. These inhalers comprise a means for releasing ameasured dose of medicament, the releasing means comprising a means forpriming the device by applying a preload capable of actuating deliverymeans, a means for applying a resisting pneumatic force capable ofpreventing actuation of the delivery means and a release device capableof freeing the resisting pneumatic force to allow the preload to actuatethe delivery means and dispense the medicament. The pneumatic resistingforce can be established by mechanisms comprising, for example, adiaphragm, a piston cylinder, a bellows or a spring. Inhalation througha valve or past a vane mechanism allows the preload to actuate anaerosol valve to release medicament.

Adherence could be monitored for such inhalers by determining when thedevice is primed and/or when the aerosol valve opens. Again, theintroduction of a MEMS barometric pressure sensor anywhere in theairflow path through the inhaler or anywhere in fluid communication withthe airflow path, in combination with means for determining when thedevice has been primed and/or when the aerosol valve opens, may enablecompliance monitoring.

Priming the device may result in both a preload being applied to thedelivery means and a load being applied to an electronic switch. Thisswitch may be connected to an input of the processor such that theprocessor receives an electronic pulse when the device is primed.Alternatively or additionally, an electronic switch may be arranged tobe actuated by motion of the aerosol valve or of the valve or vanemechanism preceding the aerosol valve. This switch may be connected toan input of the processor such that the processor receives an electronicpulse when aerosol is released to the flow channel through which thepatient inhales. The switch may be, for example, mechanical, optical,proximity based or an accelerometer.

It should be noted that because MEMS barometric pressure sensors respondto environmental barometric pressure, which can change over time,attention should be paid to the initial reading that any subsequentsensor output signal analysis is based upon. An automatic zero reading(e.g., tare) may be performed immediately prior to monitoring anyinhalation signal. While it is possible for this value to change overtime in response to changes in local environmental barometric pressure,it may not be expected to cause any issues if a treatment is completedwithin a few minutes. A second barometric chip may be used to keep trackof barometric activity, allowing the primary chip to be used exclusivelyfor breath detection.

The point at which dosing is complete (e.g., where lung volume peaks)may correspond to the point at which flow reverses direction. Thus, theprocessor may make a determination that dosing is complete when the datafrom the pressure sensor indicates that flow direction has reversed.

Not all processing needs to be done by the module. Any or all processingmay be offloaded to an external data processing device. A wirelessscheme (for example comprising a BLE module) may be used to transmitpatient flow profiles to an app which could then calculate specificbreathing parameters. The inhaler may thereby offload the processingrequired for such a task to, for example, a smart phone processor. Thismay facilitate the smallest form factors possible for the inhalers. Afurther advantage of this approach may be that software running on asmart phone may be changed more readily than software running on aninhaler.

The processor may provide the information gathered by the sensor andprocessed by the processor to a remote device through a transceiver. Thetransceiver is described in detail below. Although the examples belowuse wireless communication, an inhaler may communicate via other modes,including use of a wire.

The addition of transceiver may make it possible to monitor patientadherence and compliance and communicate such information, for exampleincluding patient flow profiles, to a user device, such as a smartphone, tablet, or computer. The information may be sent to a server,either directly from an inhaler or from a user device. From a userdevice data can be communicated to a caregiver's device, for example adoctor's personal computer (PC). This could be done using a wiredconnection, for example via a Universal Serial Bus (USB) port. Usingwireless technology, it may be possible to communicate results to theoutside world without interrupting the product housing in anysignificant way. Suitable wireless technologies could include, forexample, WiFi technologies such as IEEE 802.11, Medical Body AreaNetwork (MBAN) technologies such as IEEE 802.15, Near FieldCommunication (NFC) technologies, mobile technologies, such as 3G and4G, and Bluetooth™ technologies, such as Bluetooth™ Low Energy (BLE). Awireless transceiver, for example in the form of a BLE chip, may beconnected to the miniature sensor or integrated with it.

Such wireless connectivity may be used, for example, to report deviceactuation and/or sensed inhalation with date and time stamps in realtime. This data may be processed externally and if the result of suchprocessing is that it is determined that a prescription should berefilled, an alert may be sent to the patient and/or caregiver and/orpharmacist. Alerts may be provided via one or more user interfaces ofthe inhaler (for example an LED and/or a buzzer) or via text message oremail. As an example, if no dosing report is received within apredetermined period following a scheduled dosing time, a reminder maybe sent to the patient and/or caregiver. Alerts may also be generatedfor example if use frequency is exceeding a safe threshold.

The compliance module may communicate directly or indirectly with one ormore of: a user device (such as a mobile phone e.g. a smartphone, atablet, a laptop or a desktop computer) of a patient, or of a caregiver(such as a doctor, nurse, pharmacist, family member or carer), a servere.g. of a health service provider or inhaler or drug manufacturer ordistributor or a cloud storage system. Such communication may be via anetwork such as the Internet and may involve a dedicated app, forexample on the patient's smartphone.

Compliance monitoring means (such as one or more sensors, e.g. a deviceactuation sensor such as a mechanical switch to detect adherence andcompliance reporting means, e.g. a miniature pressure sensor to detectsufficient flow for proper dose delivery) and compliance reporting means(such as a wireless transmitter or wired output port) may be included ina single module. This module may be sold as a separate inhaleraccessory/upgrade for attachment to an existing or slightly modifieddesign of inhaler. The compliance monitoring module may be incorporatedinto the inhaler during manufacture. The compliance monitoring modulemay be in a single physical unit. The compliance monitoring module maybe in multiple units. In the case of an inhaler accessory version, themodule may consist of one or more attachable units. In the case of amodule incorporated into an inhaler, the individual components may belocated in any suitable locations in or on the inhaler and need not begrouped together or connected any further than required for them tofunction.

FIGS. 7A-F are example diagrams of various states of an inhaler 700 andits indications. FIGS. 7A-B are example diagrams that show an inhaler700 indicating that a dose of medication is ready for inhalation. Theinhaler 700 may be an example of the inhaler 100. When a user opens amouthpiece cover 780, a dose may be ready. For example, a dose ofmedicament may be delivered from a reservoir (e.g., the reservoir 178)to a dosing cup (e.g., the dosing cup 175). The inhaler 700 may make a“click” sound and/or may illuminate one or more indicators 752 toindicate a “dose ready” state of the inhaler. For example, to indicatethe “dose ready” state, the indicator 752 a may illuminate and theindicator 752 b may remain turned off, may be flashing, and/or mayilluminate. The inhaler 700 may include a button that may be pressed toready a dose of medicament either in addition to or in replacement ofthe opening of the cover 780. The inhaler 700 may be in a particularorientation (e.g., upright orientation) when opening the cover 780 orpressing a button to indicate the “dose ready” state.

FIGS. 7C-D are example diagrams that show the inhaler 700 indicating apressure measurement in the mouthpiece 770 exceeds a predeterminedthreshold (e.g., Peak Inspiratory Flow, acceleration, total volume,total time, and/or the like). Example methods of determining the amountof inhalation are provided herein, for example, as described inreference to FIGS. 4 and 6. The inhaler 700 may indicate that a pressuremeasurement exceeds a predetermined threshold, which for example, mayindicate that the user successfully inhaled the medication. For example,the pressure measurement (e.g., a pressure drop) may be measuredelsewhere in the inhaler 700, and the inhaler 700 may calculate the flowin the mouthpiece accordingly. The inhaler 700 may have indicators tomake a sound, vibrate, or illuminate to indicate successful inhalation.For example, both the indicator 752 a and the indicator 752 b mayilluminate for such indication. For example, the indicator 752 a maystay on and the indicator 752 b may be turned off.

FIGS. 7E-F are example diagrams that show the inhaler 700 indicatingthat the inhaler 700 is off. The inhaler 700 may indicate that theinhaler is off, for example, when a user closes the cover 780. Theinhaler 700 may make a “click” sound and/or turn off both indicators 752a and 752 b to indicate that the inhaler 700 is off (e.g., that theelectronics module 550 is powered off). Although not illustrated, theinhaler 700 may provide a dose reminder indication using of or more ofthe indicators 752 a, 752 b. For example, the inhaler may indicate thatit is time for a user to take a dose of medication. For example, theinhaler 700 may illuminate the indicator 752 a and/or the indicator 752b in a specific light pattern, color, etc. to indicate to the user thatit is time for a user to take a dose of medication. The inhaler 700 maycomprise a timer circuit that, when expires, causes the inhaler 700 touse one or more indicators to indicate that it is time for a user totake a dose of medication.

FIG. 8 is an example flow diagram that illustrates the inhaler's states(e.g., the inhaler 100) through operation. For example, the inhaler maycomprise two indicators, an indicator A and an indicator B (e.g., afirst light and a second light). At 810, an inhaler cover (e.g., cover180) may be closed and/or the indicators A and B are in states A1 andB1, respectively. For example, indicators A and B may be off in statesA1 and B1. When the inhaler (e.g., through a processor inside theinhaler) detects that the cover is open at 815, the indicators may be in(e.g., changed to) states A2 and B2 at 820. For example, the indicator Amay illuminate in state A2, and the indicator B may be off in state B2.When the inhaler detects a pressure measurement (e.g., at a firstthreshold) of the inhaler (e.g., via a pressure sensor) at 825, theindicators may be in state A3 and B3 at 830. For example, the indicatorA may illuminate in state A3, and the indicator B may be flashing instate B3. The pressure measurement may be indicative of (e.g., causedby) the user inhaling medication. The pressure measurement may be apressure reading in the mouthpiece or elsewhere in the inhaler.

When the inhaler detects that the pressure measurement of the inhalerexceeds a predetermined amount at 835 (e.g., which may be indicative ofa full dose of medication being administered to the user), theindicators A and B may be in state A4 and B4 at 840. For example, theindicator A may illuminate in state A4 and the indicator B mayilluminate in state B4. If the inhaler detects that the cover is closedat 845, then the indicators A and B may be in state A1 and B1 at 810.For example, the indicators A and B may be off in states A1 and B1. Inone or more embodiments, 825 and 830 may be omitted such that theinhaler may proceed to 835 from 820.

Example state diagrams may include the states A1, B1, A2, B2, A3, B3,A4, and B4 of the indicators A and B being in any combination of an offstate, an on state, and/or a flashing state. Moreover, if the indicatoris a light, the on state and/or flashing state may be characterized bythe light being illuminated in one or more of a plurality of colors. Theindicator may use different patterns of flashing. For example, examplestate diagrams are provided in Table 1 below:

TABLE 1 Example configurations of inhaler indicators Exam- ple StateDia- State State State State State State State State gram A1 B1 A2 B2 A3B3 A4 B4 Ex. 1 Off Off On Off On Off On On Ex. 2 Off Off On Flashing OnFlash- On On ing Ex. 3 Off Off On On On On On Off Ex. 4 Off Off OnFlashing On On On Off

In example 1, indicator A is off in state A1 (e.g., when the cover isclosed), on in state A2 (e.g., to indicate that a dose is ready), on instate A3 (e.g., while the user is inhaling), and on in state A4 (e.g.,when the dose has been administered). In example 1, indicator B is offin states B1, B2, and B3, and on in state B4. In example 2, indicator Ais off in state A1, and on in states A2, A3, and A4. In example 2,indicator B is off in state B1, flashing in states B2 and B3, and on instate B4. In example 3, indicator A is off in state A1, and on in statesA2, A3, and A4. In example 3, indicator B is off in state B1, on instates B2 and B3, and off in state B4. In example 4, indicator A is offin state A1, and on in states A2, A3, and A4. In example 4, indicator Bis off in state A1, flashing in state B2, on in state B3, and off instate B4. There may be other methods of indicating the states. Forexample, the indicators may include multi-light and/or multi-colorconfigurations.

An inhaler (e.g., the inhaler 100) may have a single indicator, whichfor example, may be a light. The indicator light may have multiplecolors and/or multiple modes of indication. For example, the indicatorlight may be on, off, flashing, and/or illuminate in multiple colors.The indicator light may use different patterns of flashing. FIG. 9 is anexample flow diagram of an inhaler with a single indicator (e.g.,indicator light). At 910, the cover of the inhaler may be closed and theindicator light is in state 1. For example, the indicator light may beoff in state 1. When the inhaler (e.g., through a processor inside theinhaler) detects that the cover is open at 915, the indicator may be in(e.g., changed to) state 2 at 920. For example, the indicator mayilluminate or flash in state 2. When the inhaler detects a pressuremeasurement (e.g., at a first threshold) of the inhaler (e.g., via apressure sensor), the indicator may be in state 3 at 930. For example,the indicator may illuminate or flash in state 3. The pressuremeasurement may be indicative of (e.g., caused by) the user inhalingmedication.

When the inhaler detects that the pressure measurement of the inhalerexceeds a predetermined amount at 935 (e.g., which may be indicative ofa full dose of medication being administered to the user), the indicatormay be in state 4 at 940. For example, the indicator may illuminate instate 4. If the inhaler detects that the cover is closed at 945, thenthe indicator may be in state 1 at 910. For example, the indicator maybe off in state 1. In one or more embodiments, 925 and 930 may beomitted such that the inhaler may proceed to 935 from 920.

The indicator may be on, off, flash, and/or illuminate in differentcolors to indicate different states. For example, indicator may indicatestate 2 with green and state 4 with blue.

Example state diagrams may include the states A1, B1, A2, B2, A3, B3,A4, and B4 of the indicator being in any combination of an off state, anon state, and/or a flashing state. Moreover, if the indicator is alight, the on state and/or flashing state may be characterized by thelight being illuminated in one or more of a plurality of colors. Theindicator may use different patterns of flashing. For example, examplestate diagrams are provided in Table 2 below:

TABLE 2 Example configurations of an inhaler indicator Example StateDiagrams State 1 State 2 State 3 State 4 Ex. 1 Off Flash Flash On Ex. 2Off On On Off Ex. 3 Off On - Color 1 On - Color 1 On - Color 2 Ex. 4 OffOn - Color 1 Flash On - Color 2 Ex. 5 Off Off Off On Ex. 6 Off On -Color 1 On - Color 2 On - Color 3

In example 1, the indicator is off in state A1 (e.g., when the cover isclosed), flashing in state 2 (e.g., to indicate that a dose is ready),flashing in state 3 (e.g., while the user is inhaling), and on in state4 (e.g., when the dose has been administered). In example 2, theindicator is off in state 1, and on in states 2, 3, and off in state 4.In example 3, the indicator is off in state 1, on in a first color instates 2 and 3, and on in a second color in state 4. In example 4, theindicator is off in state A1, on in a first color in state 2, flashingin state 3, and on in a second color in state 4. In example 5, theindicator is off in states 1, 2, and 3, and on in state 4. In example 6,the indicator is off in state 1, on in a first color in state 2, on in asecond color in state 3, and on in a third color in state 4. There maybe other methods of indicating the states. For example, the indicatorsmay include multi-light and/or multi-color configurations.

The inhaler (e.g., the inhaler 100 may determine that the reservoir isempty, for example, via a dose counter. The dose counter may bemechanical and/or electrical. For example, the electronics module of theinhaler may determine that the reservoir is empty. In an example, thedose counter may be configured to count down the number of availabledoses based on actuations of the cover, which for example, maycorrespond to dispensing of medication into a dosing cup. When theinhaler determines that the reservoir is empty and when the cover issubsequently opened, the inhaler may leave the indicator(s) in the offstate. This, for example, may indicate to the user that the inhaler isnot ready for inhalation because the inhaler is out of medication. Theinhaler may indicate that the reservoir is empty using one or more ofthe indication techniques described herein (e.g., sold light, coloredlight, flashing light, one or more indicators, etc.).

Although not illustrated, the examples provided herein (e.g., withreference to FIGS. 8-9 and the associated description and examples) mayinclude one or more additional indications. For example, the inhaler mayfurther provide a dose reminder indication to the user. The dosereminder indication may indicate that it is time for the user to take adose of medication. For example, the inhaler may use one or moreindicators (e.g., lights, sounds, haptic feedback, etc.) to provide adose reminder to the user.

Although described primarily with reference to visual indicators (e.g.,one or more lights and/or light states), one or more of theembodiments/examples described herein may comprise other indicators. Forexample, the indicators may comprise visual indicators (e.g., one ormore lights and/or light states), audible indicators (e.g., one or morebuzzers/speakers and/or sounds), and/or haptic feedback indicators(e.g., one or more haptic feedback devices and/or haptic feedbackstates/operations).

What is claimed:
 1. An inhaler comprising: a mouthpiece cover; a dosingcup; a medication reservoir configured to deliver a dose of medicationinto the dosing cup upon the mouthpiece cover moving from a closedposition to an open position; a pressure sensor; a light; and aprocessor configured to control the light to be in a first state whenthe mouthpiece cover is in the closed position, a second state uponmedication being delivered from the medication reservoir to the dosingcup, and a third state based on an output of the pressure sensor.
 2. Theinhaler of claim 1, wherein the first state is off, the second state ison, and the third state is off.
 3. The inhaler of claim 1, wherein thefirst state is off, the second state is on, and the third state isflashing.
 4. The inhaler of claim 1, wherein the first state is off, thesecond state is flashing, and the third state is on.
 5. The inhaler ofclaim 1, wherein the third state is indicative of a successfulinhalation from the inhaler.
 6. The inhaler of claim 1, wherein theprocessor is configured to control the light to be in the third statewhen the output received from the pressure sensor exceeds apredetermined threshold.
 7. The inhaler of claim 6, wherein the outputof the pressure sensor comprises a pressure measurement corresponding toan amount of airflow through a mouthpiece of the inhaler.
 8. The inhalerof claim 1, wherein the processor is configured to control the light tobe in a fourth state based on a number of actuations of the mouthpiececover from the closed position to the open position.
 9. The inhaler ofclaim 8, wherein the fourth state is indicative of no doses ofmedication remaining in the inhaler.
 10. The inhaler of claim 1, whereinthe processor is configured to control the light to be in a fourth stateto indicate that it is time for the user to take the dose of medication.11. A method of signaling states of an inhaler to a user, the methodcomprising: controlling a light of the inhaler to be in a first statewhen a mouthpiece cover of the inhaler is in a closed position;delivering a dose of medication into a dosing cup upon the mouthpiececover moving from the closed position to an open position; controllingthe light to be in a second state upon the dose of medication beingdelivered into the dosing cup; receiving a signal from a pressure sensorof the inhaler, the signal indicative of a drop of pressure within theinhaler; determining that the signal exceeds a predetermined threshold;and controlling the light to be in a third state based on the signalexceeding the predetermined threshold.
 12. The method of claim 11,wherein the first state is off, the second state is on, and the thirdstate is off.
 13. The method of claim 11, wherein the first state isoff, the second state is on, and the third state is flashing.
 14. Themethod of claim 11, wherein the first state is off, the second state isflashing, and the third state is on.
 15. The method of claim 11, whereinthe third state is indicative of a successful inhalation.
 16. The methodof claim 11, wherein the signal from the pressure sensor comprises apressure measurement corresponding to an amount of airflow through aflow channel of the inhaler.
 17. The method of claim 11, furthercomprising controlling the light to be in a fourth state based on anumber of actuations of the mouthpiece cover from the closed position tothe open position.
 18. The method of claim 17, wherein the fourth stateis indicative of no doses of medication remaining in the inhaler. 19.The method of claim 11, further comprising controlling the light to bein a fourth state to indicate that it is time for the user to take thedose of medication.
 20. The method of claim 11, further comprisingdelivering the dose of medication to the user via a flow channel of theinhaler when the user inhales from a mouthpiece of the inhaler.